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Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test (OFTaPLR)

Primary Purpose

Shock, Septic

Status

Terminated

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Passive Leg Raising Test

Standard of care

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring shock, septic, hemodynamics, algorithms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients >18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.

Exclusion Criteria:

> 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure>20 cm H2O.

Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding.

Serious adverse events:

Trombosis in arteria femoralis. Death during the study period.

Sites / Locations

Karolinska Institutet Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Passive Leg Raising

Standard of care

Arm Description

Before decision on fluid administration a passive leg raising test is performed. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.

Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.

Outcomes

Primary Outcome Measures

weight gain

Secondary Outcome Measures

ICU length of stay

Number of days spent in the ICU: time and date of discharge from the ICU minus time and date of admission to the ICU. A started but not yet completed day is counted as one.

Cumulative fluid balance study day 1,2,3

Fluids in-Fluids out during the study period.

30 day mortality

Is the patient alive or dead after 30 days?

Organ support during ICU stay

Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.

ICU discharge status

Alive or dead at discharge from the ICU?

Full Information

NCT ID

NCT02301585

First Posted

September 14, 2014

Last Updated

February 8, 2016

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm, Svenska militärläkarföreningen

1. Study Identification

Unique Protocol Identification Number

NCT02301585

Brief Title

Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test

Acronym

OFTaPLR

Official Title

Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

The study was stopped because of futility due to unexpected low weight gain in both groups.

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Region Stockholm, Svenska militärläkarföreningen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department. Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Septic

Keywords

shock, septic, hemodynamics, algorithms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Passive Leg Raising

Arm Type

Experimental

Arm Description

Before decision on fluid administration a passive leg raising test is performed. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.

Intervention Type

Procedure

Intervention Name(s)

Passive Leg Raising Test

Intervention Description

Before decision on fluid administration a passive leg raising test is performed. The results are interpreted according to a treatment protocol. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.

Intervention Type

Procedure

Intervention Name(s)

Standard of care

Intervention Description

Patients are treated according to Surviving Sepsis Guidelines

Primary Outcome Measure Information:

Title

weight gain

Time Frame

3 days

Secondary Outcome Measure Information:

Title

ICU length of stay

Description

Number of days spent in the ICU: time and date of discharge from the ICU minus time and date of admission to the ICU. A started but not yet completed day is counted as one.

Time Frame

measured within 90 days after inclusion

Title

Cumulative fluid balance study day 1,2,3

Description

Fluids in-Fluids out during the study period.

Time Frame

Study day 1,2,3

Title

30 day mortality

Description

Is the patient alive or dead after 30 days?

Time Frame

30 days from inclusion in the study

Title

Organ support during ICU stay

Description

Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.

Time Frame

ICU-stay

Title

ICU discharge status

Description

Alive or dead at discharge from the ICU?

Time Frame

End of ICU stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients >18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids. Exclusion Criteria: > 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure>20 cm H2O. Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding. Serious adverse events: Trombosis in arteria femoralis. Death during the study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christer Svensen, Prof

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet Södersjukhuset

City

Stockholm

ZIP/Postal Code

11883

Country

Sweden

12. IPD Sharing Statement

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